Introduction – Rheumatology as Medical Device India:
This article deals with the latest rules of Rheumatology Products as a Medical Device India – Non Notified Medical Device Registration. Indian healthcare regulators at the Central Drugs Standard Control Organization (CDSCO) have issued substantial new risk based classification lists for Rheumatology as Medical Device in India. All Rheumatology Products now need to be registered in order to comply with the latest Medical Device Rules in India ( i.e. 30th September, 2021). Below is a table which helps manufacturers classify their products and apply with the Indian Health Ministry Accordingly. The total number of Devices classified are 11.
Table: Rheumatology as Medical Device India
| S.No | Device Name | Intended Use | Risk Based Classification |
| 1 | Back Brace | Back Brace Provides with Strong Support to lower back and waist, Stabilize and Support your Shoulders, Chest and back with this posture correction brace. | I |
| 2 | Canes | Canes may help seniors and elderly people with types of arthritis like patellofemoral or other knee, hip and even hand arthritis. | I |
| 3 | Lateral Wedge insoles | Intended for treatment of pain in patients with medical knee Osteoarthritis | I |
| 4 | Grab bars in Showers and tubes | The horizontal bars on the walls are used to get in and out of the tub. The vertical bar on the wall containing the controls serves as a support for the user to turn the water on and | I |
| 5 | Shoe Insert | A medical Insole is a device intended for medical purposes that is placed inside a shoe to relieve the symptoms of athlete’s foot infection by absorbing moisture | I |
| 6 | Reachers | Reacher will allows arthritis Suffers to pick up or extend their reach to retrieve items otherwise not possible | I |
| 7 | Orthopaedic Pillow | Designed to correct body positioning in bed or while lying on any other surface | I |
| 8 | Orthopaedic Shoes | Orthopaedic Shoes protect the toes,feet,and ankles from injuries such as crushing of the toes,twisting of the ankles and torn muscles in the legs. | I |
| 9 | Stairway Chair Lift | Intended to take persons up the staircase with the ease of usability | I |
| 10 | Toilet Frames | Intended to help the patients with rheumatoid. Osteoarthritis ,Elderly arthritis, seniors with arthritis.Raised toilet seats can help to minimize the problem | I |
| 11 | Bottle and Jar Openers | Intended for people ,who has arthritic hands of fingers,opening jars and bottles is often difficult and painful | I |
Conclusion:
The above article is taken from S.O 648(E) & G.S.R 102(E) which mentions that all Medical Devices will be regulated in a phase manner. The CDSCO has classified the MDR in India as Appendix A based on the Intended Use, Risks Associated and Other Parameters Specified with the device. The above table has the general intended use against each device, however if any specific intended use for a particular device, it has to be mentioned by the manufacturer. The list is dynamic and is subject to changes. To obtain MDR in India, contact Morulaa. We at Morulaa will help you understand the latest rules for Rheumatology as a Medical Device India. We are a turnkey solution provider with an in-house Medical Device Consultancy team to conduct registrations of Medical Devices in India. In order to comply with the deadline 30th September of Rheumatology Products as a Medical Device in India contact us at [email protected]. You can also subscribe to our website to learn about the Latest Rules and Medical Regulations.